FDA Adverse Event Injury Summary report: N

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

MDR report key: 2895677 · Received January 3, 2013

Report

Report Number: 3004209178-2013-90048
Event Type: Injury
Date Received: January 3, 2013
Date of Event: December 17, 2012
Report Date: December 17, 2012
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NJ
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

THE INSULIN PUMP ALARMED BUTTON ERROR AND HAD NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. UNABLE TO PERFORM THE FUNCTIONAL TEST, INCLUDING THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY TEST AND LOW RESERVOIR ALARM DUE TO BUTTON AND KEYPAD ANOMALY. THE INSULIN PUMP HAD A SCRATCHED DISPLAY WINDOW AND CRACKED RESERVOIR TUBE LIP.

Additional Manufacturer Narrative · 1

CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT THE PARAMEDICS WERE CALLED AND HER BLOOD GLUCOSE WAS TREATED WITH GLUCAGON SHOTS. THE BLOOD GLUCOSE READING AT THE TIME THE PARAMEDICS ARRIVED WAS 26MG/DL. THE CUSTOMER MENTIONED RECEIVING A BUTTON ERROR ALARMS. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2414	PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-523NAL

Patients

Seq	Age	Sex	Outcome	Treatment
1	46 YR		Required Intervention